Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients

Gastric Cancer Clinical Trial

Official title:

An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518529
• Other study ID #: GC12
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2015
• Last updated: August 5, 2015
• Start date: February 2001
• Est. completion date: December 2002

Study information

• Verified date: August 2015
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton.

• Male or female patients over 18 years of age.

• Patients with a life expectancy of at least four months.

• Karnofsky index for performance status of >70%

• Patients must have given written informed consent.

Exclusion Criteria:

• Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period.

• History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix.

• Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy.

• Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy.

• Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids.

• Known immunodeficiency.

• Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.

• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or up to week 16 during this study.

• Previous G17DT treatment.

• Haematological indicators:

Haemoglobin <10.0g/dl Neutrophils < 2.0 x 109/l Platelets <100 x 109/l

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• G17DT

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Cancer Advances Inc.	ChapelPharma Ltd, PPD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurable Gastrin-17 Antibody Titer		Up to Week 52	No
Secondary	Injection tolerability	Subjects were monitored for injection site reactions and/or swelling at the injections site.	Up to Week 52	Yes
Secondary	Overall Survival from date of randomization to death or end of study		Up to December 2002	No